Cuff stitching reinforcement

ABSTRACT

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. A cuff may be coupled to the stent so that a flat, bottom edge of the cuff lies adjacent the proximal end of the stent. A pattern of stitches may be circumferentially disposed around the flat bottom edge of the cuff, the pattern of stitches alternating between stitches sewn to the cuff only and stitches sewn to both the cuff and the stent.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of the filing date of U.S.Provisional Patent Application No. 61/909,496, filed Nov. 27, 2013, thedisclosure of which is hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates to heart valve replacement and, inparticular, to collapsible prosthetic heart valves. More particularly,the present invention relates to collapsible prosthetic heart valveshaving improved cuff attachments.

Prosthetic heart valves that are collapsible to a relatively smallcircumferential size can be delivered into a patient less invasivelythan valves that are not collapsible. For example, a collapsible valvemay be delivered into a patient via a tube-like delivery apparatus suchas a catheter, a trocar, a laparoscopic instrument, or the like. Thiscollapsibility can avoid the need for a more invasive procedure such asfull open-chest, open-heart surgery.

Collapsible prosthetic heart valves typically take the form of a valvestructure mounted on a stent. There are two types of stents on which thevalve structures are ordinarily mounted: a self-expanding stent and aballoon-expandable stent. To place such valves into a delivery apparatusand ultimately into a patient, the valve must first be collapsed orcrimped to reduce its circumferential size.

When a collapsed prosthetic valve has reached the desired implant sitein the patient (e.g., at or near the annulus of the patient's heartvalve that is to be replaced by the prosthetic valve), the prostheticvalve can be deployed or released from the delivery apparatus andre-expanded to full operating size. For balloon-expandable valves, thisgenerally involves releasing the valve, assuring its proper location,and then expanding a balloon positioned within the valve stent. Forself-expanding valves, on the other hand, the stent automaticallyexpands as the sheath covering the valve is withdrawn.

SUMMARY OF THE INVENTION

In some embodiments, a prosthetic heart valve includes a collapsible andexpandable stent having a proximal end, a distal end, an annulus sectionadjacent the proximal end and an aortic section adjacent the distal end,the stent including a plurality of struts. A cuff may be coupled to thestent so that a flat, bottom edge of the cuff lies adjacent the proximalend of the stent. A pattern of stitches may be circumferentiallydisposed around the flat bottom edge of the cuff, the pattern ofstitches alternating between stitches sewn to the cuff only and stitchessewn to both the cuff and the stent.

In some embodiments, a prosthetic heart valve may include a collapsibleand expandable stent having a proximal end, a distal end, an annulussection adjacent the proximal end and an aortic section adjacent thedistal end, the stent including a plurality of struts and a plurality ofcommissure features. A cuff may be coupled to the stent so that a topedge of the cuff lies adjacent the plurality of commissure features anda plurality of tethers incorporated along the top edge of the cuff andcoupled to the cuff only.

In some embodiments, a method of making a prosthetic heart valve mayinclude (i) providing a collapsible and expandable stent having aproximal end, a distal end, an annulus section adjacent the proximal endand an aortic section adjacent the distal end, the stent including aplurality of struts, (ii) coupling a cuff to the stent so that a flatbottom edge of the cuff lies adjacent the proximal end of the stent, and(iii) sewing a pattern of stitches circumferentially around the flatbottom edge of the cuff, the pattern of stitches alternating betweenstitches sewn to the cuff only and stitches sewn to both the cuff andthe stent.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed heart valves aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a side elevational view of a conventional prosthetic heartvalve;

FIG. 2 is a highly schematic cross-sectional view showing anotherprosthetic heart valve disposed within a native valve annulus;

FIG. 3A is a developed view of a cuff having a series of peaks;

FIG. 3B is a perspective side view of the cuff of FIG. 3A after theattachment portions of the cuff have been coupled together;

FIG. 4A is a partial schematic side view of a first variation of aprosthetic heart valve having a cuff coupled to a stent, the cuff havinga plurality of cutouts;

FIG. 4B is a partial schematic side view of a second variation of aprosthetic heart valve having a cuff coupled to a stent, the cuff havinga substantially straight inflow edge;

FIGS. 4C-4D are partial schematic side views of examples of cuffs havingsubstantially straight inflow edges;

FIG. 4E is a highly schematic end view of the prosthetic heart valve ofFIG. 4B disposed within a native valve annulus;

FIG. 5 is a developed view of a cuff having stitches attached near theinflow end;

FIG. 6 is a highly schematic end view of the prosthetic heart valve ofFIG. 5 disposed within a native valve annulus;

FIGS. 7A and 7B are a highly schematic end views of a prosthetic heartvalve disposed within a generally elliptical native valve annulus, theprosthetic heart valve having and not having cuff inflow end stitches,respectively; and

FIG. 8 is a developed view of a cuff having stitches attached near theoutflow edge.

Various embodiments of the present invention will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the invention and are thereforenot to be considered limiting of its scope.

DETAILED DESCRIPTION OF THE INVENTION

Inaccurate deployment and anchoring of a prosthetic heart valve mayresult in the leakage of blood between the implanted heart valve and thenative valve annulus, commonly referred to as perivalvular (or“paravalvular”) leakage. In aortic valves, this leakage enables blood toflow from the aorta back into the left ventricle, reducing cardiacefficiency and putting a greater strain on the heart muscle.Additionally, calcification of the aortic valve may affect performanceand the interaction between the implanted valve and the calcified tissueis believed to be relevant to leakage, particularly when the nativevalve leaflets have not first been resected. To reduce the risk ofleakage, adequate anchoring and sealing are helpful. Moreover,anatomical variations from one patient to another may affect wear anddurability.

As used herein, the term “proximal,” when used in connection with aprosthetic heart valve in the aortic position, refers to the end of theheart valve closest to the heart when the heart valve is implanted in apatient, whereas the term “distal,” when used in connection with aprosthetic heart valve, refers to the end of the heart valve farthestfrom the heart when the heart valve is implanted in a patient. Also, asused herein, the word “about” is intended to mean that slight variationsfrom absolute are included within the scope of the valve recited, forexample, due to manufacturing tolerances.

FIG. 1 shows a collapsible stent-supported prosthetic heart valve 100including a stent 102 and a valve assembly 104 as is known in the art.The prosthetic heart valve 100 is designed to replace the nativetricuspid valve of a patient, such as the native aortic valve. It shouldbe noted that while the inventions herein are described predominantly inconnection with their use with a prosthetic aortic valve and a stenthaving a shape as illustrated in FIG. 1, the valve could be a bicuspidvalve, such as the mitral valve, and the stent could have differentshapes, such as a flared or conical annulus section, a less-bulbousaortic section, and the like, and a differently shaped transitionsection.

Prosthetic heart valve 100 will be described in more detail withreference to FIG. 1. Prosthetic heart valve 100 includes expandablestent 102 which may be formed from biocompatible materials that arecapable of self-expansion, such as, for example, shape memory alloys,such as the nickel-titanium alloy known as “Nitinol” or other suitablemetals or polymers. Stent 102 extends from proximal or annulus end 130to distal or aortic end 132, and includes annulus section 140 adjacentproximal end 130, transition section 141, and aortic section 142adjacent distal end 132. Annulus section 140 has a relatively smallcross-section in the expanded condition, while aortic section 142 has arelatively large cross-section in the expanded condition. Preferably,annulus section 140 is in the form of a cylinder having a substantiallyconstant diameter along its length. Transition section 141 may taperoutwardly from annulus section 140 to aortic section 142. Each of thesections of stent 102 includes a plurality of struts 160 forming cells162 connected to one another in one or more annular rows around thestent. For example, as shown in FIG. 1, annulus section 140 may have twoannular rows of complete cells 162 and aortic section 142 and transitionsection 141 may each have one or more annular rows of partial cells 162.Cells 162 in aortic section 142 may be larger than cells 162 in annulussection 140. The larger cells in aortic section 142 better enableprosthetic valve 100 to be positioned in the native valve annuluswithout the stent structure interfering with blood flow to the coronaryarteries.

Stent 102 may include one or more retaining elements 168 at distal end132 thereof, retaining elements 168 being sized and shaped to cooperatewith female retaining structures (not shown) provided on a deploymentdevice configured to deploy the prosthetic valve 100 in the native valveannulus of a patient. The engagement of retaining elements 168 with thefemale retaining structures on the deployment device helps maintainprosthetic heart valve 100 in assembled relationship with the deploymentdevice, minimizes longitudinal movement of the prosthetic heart valverelative to the deployment device during unsheathing or resheathingprocedures, and helps prevent rotation of the prosthetic heart valverelative to the deployment device as the deployment device is advancedto the target location and the heart valve deployed.

Prosthetic heart valve 100 includes valve assembly 104, preferablypositioned in annulus section 140 of the stent 102 and secured to thestent. Valve assembly 104 includes cuff 176 and a plurality of leaflets178 which collectively function as a one-way valve by coapting with oneanother. As a prosthetic aortic valve, valve 100 has three leaflets 178.However, it will be appreciated that other prosthetic heart valves withwhich the sealing portions of the present disclosure may be used mayhave a greater or lesser number of leaflets 178.

Although cuff 176 is shown in FIG. 1 as being disposed on the luminal orinner surface of annulus section 140, it is contemplated that cuff 176may be disposed on the abluminal or outer surface of annulus section 140or may cover all or part of either or both of the luminal and abluminalsurfaces. Both cuff 176 and leaflets 178 may be wholly or partly formedof any suitable biological material or polymer such as, for example,polytetrafluoroethylene (PTFE), ultra-high molecular weightpolyethylene, polyurethane, polyvinyl alcohol, silicone or combinationsthereof.

Leaflets 178 may be attached along their belly portions to cells 162 ofstent 102, with the commissure between adjacent leaflets 178 attached tocommissure features 166 of the stent. As can be seen in FIG. 1, eachcommissure feature 166 may lie at the intersection of four cells 162,two of the cells being adjacent one another in the same annular row, andthe other two cells being in different annular rows and lying inend-to-end relationship. Preferably, commissure features 166 arepositioned entirely within annulus section 140 or at the juncture ofannulus section 140 of stent 102 and transition section 141. Commissurefeatures 166 may include one or more eyelets which facilitate thesuturing of the leaflet commissure to stent 102.

Prosthetic heart valve 100 may be used to replace a native aortic valve,a surgical heart valve or a heart valve that has undergone a surgicalprocedure. Prosthetic heart valve 100 may be delivered to the desiredsite (e.g., near the native aortic annulus) using any suitable deliverydevice. During delivery, prosthetic heart valve 100 is disposed insidethe delivery device in the collapsed condition. The delivery device maybe introduced into a patient using a transfemoral, transapical,transseptal or any other percutaneous approach. Once the delivery devicehas reached the target site, the user may deploy prosthetic heart valve100. Upon deployment, prosthetic heart valve 100 expands so that annulussection 140 is in secure engagement within the native aortic annulus.When prosthetic heart valve 100 is properly positioned inside the heart,it works as a one-way valve, allowing blood to flow from the leftventricle of the heart to the aorta, and preventing blood from flowingin the opposite direction.

FIG. 2 is a highly schematic cross-sectional illustration of prostheticheart valve 200 disposed within native valve annulus 250. As seen in thefigure, stent 202 has a substantially circular cross-section which isdisposed within the non-circular native valve annulus 250. At certainlocations around the perimeter of heart valve 200, crescent-shaped gaps240 form between the heart valve and native valve annulus 250. Bloodflowing through these gaps and past valve assembly 204 of prostheticheart valve 200 may be undesirable.

FIGS. 3A and 3B illustrate the outer surface of a cuff before couplingto a stent. As shown, cuff 300 includes a generally parallelogram-shapedbody 302, a series of trapezoidal or triangular peaks 304 a, 304 b, and304 c and a pair of attachment portions 306. It will be understood,however, that cuff 300 may be formed in various geometric shapes andthat illustrated configurations are merely exemplary. Peaks 304 may beused to couple cuff 300 to a stent. Body 302 extends longitudinally froman inflow end 320 to an outflow end 322, peaks 304 a, 304 b, and 304 cbeing located near outflow end 322. Attachment portions 306 are adaptedto be coupled together to form cuff 300 into the wrapped or assembledconfiguration shown in FIG. 3B. Attachment portions 306 may overlap oneanother in the wrapped configuration, and may be coupled together usinga suture, an adhesive or any other suitable means. Attachment portions306 may also abut one another and couple together. Cuff 300 may beplaced in the wrapped configuration before being coupled to a stent.Alternatively, cuff 300 may be first coupled to the stent after whichattachment portions 306 may be coupled together.

Cuff 300 is coupled to a stent and to a number of leaflets to form aprosthetic heart valve. It will be understood that the components may beassembled using various techniques and in different orders. For example,the cuff may be coupled to the stent followed by the leaflets or theleaflets may be attached to the cuff followed by assembly of both to thestent.

Two variations of the final cuff-stent assembly are described below withreference to FIGS. 4A-C. In a first variation, shown in FIG. 4A,prosthetic heart valve 400A includes stent 410A formed of a plurality ofstruts 412A, with cuff 420A coupled to the stent. Cuff 420A includesbody 422A extending between inflow end 430A and outflow end 432A.

Excess portions of cuff 420A may unduly increase the crimp profile ofheart valve 400A and may also impinge on the effective orifice area(e.g., the entrance orifice through which blood flows to the valveassembly). In order to address these concerns, excess portions 440A ofbody 422A near inflow end 430A may be trimmed using a cutting mandrel, adie or other suitable means. A fixation device may be useful in thistrimming process. One fixation device useful for this purpose is shownin U.S. Provisional Patent Application Ser. No. 61/666,174 entitled“VALVE ASSEMBLY FOR CRIMP PROFILE” filed Jun. 29, 2012, the content ofwhich is hereby incorporated by reference herein in its entirety.

The trimming of cuff 420A may be accomplished either prior to or afterthe attachment of cuff 420A to stent 410A. After completion, cutouts424A, such as the semicircular cutouts shown in FIG. 4A, are formed incuff 420A at recurring positions along the edge near inflow end 430A. Inthis variation, cutouts 424A are configured to mitigate effectiveorifice area impingement of cuff 420A during forward flow of bloodthrough inflow end 430A. Though cutouts 424A may reduce the crimpprofile of the device, in applications where prosthetic heart valve 400Ais implanted in an asymmetric annulus or in an annulus having heavilycalcified regions as described above with reference to FIG. 2, cutouts424A may not adequately seal inflow end 430A against the surroundingtissue.

In a second variation, shown in FIG. 4B, prosthetic heart valve 400Bincludes stent 410B formed of a plurality of struts 412B, with cuff 420Bcoupled to the stent. Unlike heart valve 400A, cuff 420B of heart valve400B is not trimmed along either inflow end 430B or outflow end 432B,leaving a substantially flat edge 424B near inflow end 430B. Flat edge424B may align with the proximal ends of struts 412 near inflow end430B. Flat edge 424B may present some drawbacks as explained below.

FIGS. 4C-4D are partial schematic side views of examples of cuffs havinguntrimmed inflow edges. In FIG. 4C, prosthetic heart valve 400C includesstent 410C formed of a plurality of struts 412C, with cuff 420C coupledto the stent. Cuff 420C is rolled on itself near inflow end 430C tocreate halo 436C, a ring-like portion of cuff 420C that extends pastflat edge 424C. Halo 436C may be formed of the same material as cuff420C or a different material. Additionally, halo 436C may be integrallyformed with cuff 420C or may be formed of a different portion of tissue,fabric or other cuff material that is coupled to cuff 420C throughadhesive, suture or other suitable techniques. In FIG. 4D, prostheticheart valve 400D includes stent 410D formed of a plurality of struts412D, with cuff 420D coupled to the stent. Cuff 420D is rolled on itselfnear inflow end 430D to create parachute 436D.

FIG. 4E is a highly schematic end view illustrating prosthetic heartvalve 400B of FIG. 4B disposed within native valve annulus 250 as seenthrough inflow end 430B. When cutouts, such as those shown in FIG. 4A,are not formed in cuff 420B, portions of the cuff may bend inwardlyduring forward flow of blood. Specifically, bent portions 440 of cuff420B that are not directly attached to struts 412B of stent 410B foldinwardly toward the central axis of prosthetic heart valve 400B,diminishing the effective orifice area 450 through which blood may flow.In some experiments, it has been found that bent portions 440 maydiminish the total effective orifice area 450 by as much as about 10% toabout 20%. Moreover, blood flowing through regions near bent portions440 may be directed outside of cuff 420B as opposed to flowing throughorifice area 450 of the valve assembly, leading to perivalvular leakage.Thus, bent portions 440 may cause regurgitation and other inefficiencieswhich reduce cardiac performance. Similar issues may also arise inexamples having untrimmed portions as shown in FIGS. 4C and 4D.

Several techniques will be described to reduce the formation of bentportions in the cuff and to avoid constriction of the effective orificearea through the prosthetic heart valve. FIG. 5 illustrates one suchtechnique, which uses stitches to reduce bent portions of the cuff. Forthe sake of illustration, cuff 500 is shown flat, as if stretched outand only a portion of a stent is shown in detail. Cuff 500 includes body502, a series of large peaks 504 a, 504 b, and 504 c projecting from oneedge of body 502, and a pair of attachment portions 506, one on eachlongitudinal end of body 502. To minimize the formation of bent portionsof the cuff during use, as shown in FIG. 4E, a stitching technique maybe applied along flat edge 524 of body 502 near inflow end 530. In oneexample, a stitch pattern P may be disposed along flat edge 524 toeliminate or minimize bending of the cuff.

An enlarged detailed view of FIG. 5 is shown of body 502 as well asportions of select struts 552 a, 552 b (shown in broken lines) to whichbody 502 will be attached. For the sake of clarity, the remainingportions of the stent are not shown. As shown in the detailed view, whentwo struts 552a and 552b join at the inflow end of stent 550, ahorseshoe 554 is formed. Stitch pattern P may include a first horseshoelocking stitch L1 anchored at each horseshoe 554. Between adjacenthorseshoe locking stitches L1, stitch pattern P may include additionallocking stitches L2 sewn to cuff 500 only, as shown in the enlargeddetailed view in FIG. 5. Each locking stitch may include two threadsthat entwine together at the cuff. Although FIG. 5 shows two suchlocking stitches L2 between adjacent horseshoe locking stitches L1, cuff500 may include a greater or lesser number of locking stitches L2 asdesired. To get from one horseshoe locking stitches L1 to another, anytype of stitch may be used though locking stitches L2 are shown whichminimize bulkiness. Thus, stitch pattern P may begin at the attachmentportion 506 at one end of cuff 500 and form a recurring pattern of asingle horseshoe locking stitch L1 coupling cuff 500 to a horseshoe 554of stent 550 and two additional locking stitches L2 sewn to the cuffonly. Stitch pattern P may begin and end in the attachment portions 506so that the beginning and end knots are hidden when the cuff 500 isfully attached to stent 550 and the attachment portions are joinedtogether.

Such a stitching technique allows the prosthetic heart valve to achievea small crimp profile when collapsed for delivery, while securing eachsection of cuff 500 to stent 550 and minimizing bending of cuff tissueinto the flow area. Additionally, it is common to create a stent 550having a fully-expanded diameter that is greater than the diameter thestent will have in use. Thus, stitch pattern P may have the addedbenefit of ensuring optimal valve performance by limiting cuff 500 fromover-expanding outside the optimal use range. Finally, stitch pattern Pmay reduce or eliminate the inward bending of cuff 500 at inflow end530, thereby improving sealing by providing a larger landing zone andmaintaining the effective orifice area through which blood may flow,while at the same time increasing the landing area along which thenative valve annulus may be positioned relative to the prosthetic heartvalve allowing easier placement by the physician. Larger landing areasmay provide more forgiving placement accuracy. Stitch pattern P mayprovide these benefits while not unduly increasing the crimp profile ofthe prosthetic heart valve.

FIG. 6 is a highly schematic end view illustrating prosthetic heartvalve 600 disposed within native valve annulus 250. Prosthetic heartvalve 600 includes cuff 620 coupled to stent 610. A stitching techniqueas described with reference to FIG. 5 has been applied to cuff 620.Specifically, stitch pattern P has been applied along the circumferenceof cuff 620 at its inflow end. Because of the stitching technique, bentportions 630 of the cuff are reduced, leading to a larger effectiveorifice area 650 through which blood may flow and more adequate sealingwith surrounding tissue at the inflow end of prosthetic heart valve 600.

The advantages of the stitching technique described above will also bereadily seen when a prosthetic heart valve is implanted in anirregularly-shaped or elliptical native valve annulus. FIGS. 7A and 7Bare highly schematic cross-sectional illustrations of prosthetic heartvalves 700A and 700B disposed within an elliptical native valve annulus250. Prosthetic heart valve 700A includes cuff 720A coupled to stent710A, but does not employ the stitching technique described above. Whenprosthetic heart valve 700A is deployed in elliptical native annulus250, bicuspid or mitral valves and subjected to blood flow, bentportions 730A are formed, reducing the effective orifice area 750Athrough which blood may flow. Prosthetic heart valve 700B is similar toheart valve 700A, and includes cuff 720B coupled to stent 710B. However,in prosthetic heart valve 700B, the stitching technique described abovewith reference to FIG. 5 has been applied to cuff 720B. When prostheticheart valve 700B is deployed in elliptical native annulus 250 andsubjected to blood flow, the formation of bent portions 730B isminimized, leading to great apposition of cuff 720B to stent 710B, alarger effective orifice area 750B through which blood may flow, andmore adequate sealing with surrounding tissue at the inflow end of theprosthetic heart valve.

FIG. 8 illustrates another example of a cuff for promoting the sealingof the prosthetic heart valve against surrounding tissue and maximizingthe effective orifice area through which blood may flow through theprosthetic heart valve. Cuff 800 includes body 802, a series of peaks804 a, 804 b, and 804 c at the outflow end 832 of body 802, and a pairof attachment portions 806, one on each longitudinal end of body 802.Body 802 extends between inflow end 830 and outflow end 832. To minimizethe formation of bent portions of the cuff during use, as shown in FIG.4E, a tethering technique may be applied near outflow end 832 of cuff800. In one example, a plurality of horizontal tethers T1 may be used toattach peaks 804 a, 804 b, and 804 c to one another. Though cuff 800 isshown in the flat configuration, it will be understood that when thecuff is in the wrapped configuration, one set of tethers T1 attach peak804 a to peak 804 c. Vertical tethers T2 attach the horizontal tethersT1 to one another, creating a net-like structure or web. By addingtethers T1 and T2 near outflow end 832 of cuff 800, the landing zone ofthe prosthetic heart valve is increased without unduly increasing itscrimp profile. In general, a longer landing zone corresponds to bettersealing. In some variations, instead of using separate horizontaltethers T1 and vertical tethers T2, a preformed webbing, netting or meshmay be attached to the top of body 802 or peaks 804 a, 804 b, 804 c toincrease the landing zone in a similar manner.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

In some embodiments, a prosthetic heart valve, includes a collapsibleand expandable stent having a proximal end, a distal end, an annulussection adjacent the proximal end and an aortic section adjacent thedistal end, the stent including a plurality of struts. A cuff may becoupled to the stent so that a flat, bottom edge of the cuff liesadjacent the proximal end of the stent. A pattern of stitches may becircumferentially disposed around the flat bottom edge of the cuff, thepattern of stitches alternating between stitches sewn to the cuff onlyand stitches sewn to both the cuff and the stent.

In some examples, the pattern of stitches may include a plurality oflocking stitches. The pattern of stitches may include a recurringpattern comprised of a first type of stitch and a second type of stitch.The first type of stitch may be a locking stitch sewn to the cuff only.The second type of stitch may be a locking stitch sewn to the cuff andat least a portion of the stent. The recurring pattern may include twoadjacent stitches of the first type followed by a single stitch of thesecond type. The plurality of struts may form horseshoe-shaped portionsat the proximal end of the stent, and the pattern of stitches may couplethe cuff to the horseshoe-shaped portions. The pattern of stitches mayinclude locking stitches sewn only to the cuff between thehorseshoe-shaped portions.

In some embodiments, a prosthetic heart valve may include a collapsibleand expandable stent having a proximal end, a distal end, an annulussection adjacent the proximal end and an aortic section adjacent thedistal end, the stent including a plurality of struts and a plurality ofcommissure features. A cuff may be coupled to the stent so that a topedge of the cuff lies adjacent the plurality of commissure features anda plurality of tethers incorporated along the top edge of the cuff andcoupled to the cuff only.

In some examples, the stent may include a plurality of commissurefeatures and the top edge of the cuff includes a plurality of peakscoupled to the commissure features. The plurality of tethers may includeat least one vertical tether and at least one horizontal tether.Adjacent ones of the plurality of peaks may be coupled to one anothervia the at least one horizontal tether. The at least one vertical tethermay be coupled to the at least one horizontal tether. The at least onevertical tether may include multiple vertical tethers disposed betweenthe plurality of peaks.

In other embodiments, a method of making a prosthetic heart valve mayinclude (i) providing a collapsible and expandable stent having aproximal end, a distal end, an annulus section adjacent the proximal endand an aortic section adjacent the distal end, the stent including aplurality of struts, (ii) coupling a cuff to the stent so that a flatbottom edge of the cuff lies adjacent the proximal end of the stent, and(iii) sewing a pattern of stitches circumferentially around the flatbottom edge of the cuff, the pattern of stitches alternating betweenstitches sewn to the cuff only and stitches sewn to both the cuff andthe stent.

In some examples, sewing a pattern of stitches may include forming aplurality of locking stitches. Sewing a pattern of stitches may includesewing a recurring pattern comprised of a first type of stitch and asecond type of stitch. Sewing a pattern of stitches may include sewing afirst type of stitch that is a locking stitch sewn to the cuff only.Sewing a pattern of stitches may include sewing a second type of stitchthat is a locking stitch sewn to the cuff and at least a portion of thestent. The plurality of struts may form horseshoe-shaped portions at theproximal end of the stent, and sewing a pattern of stitches may includesewing the cuff to the horseshoe-shaped portions.

It will be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A prosthetic heart valve, comprising: acollapsible and expandable stent having an inflow end at a proximal end,an outflow end at a distal end, an annulus section adjacent the inflowend and an aortic section adjacent the outflow end, the stent includinga plurality of struts forming a plurality of cells disposed in rows; acuff coupled to the stent so that a flat bottom edge of the cuff liesadjacent the inflow end of the stent, the cuff fully covering each cellof a proximal-most row of cells closest to the inflow end of the stent;and a pattern of stitches circumferentially disposed around the flatbottom edge of the cuff, the pattern of stitches alternating betweenstitches of a first type having a first shape and being sewn to the cuffonly and stitches of a second type having a second shape different fromthe first shape and being sewn to both the cuff and the stent.
 2. Theprosthetic heart valve of claim 1, wherein the pattern of stitchesincludes a plurality of locking stitches.
 3. The prosthetic heart valveof claim 1, wherein the first type of stitch is a locking stitch sewn tothe cuff only.
 4. The prosthetic heart valve of claim 1, wherein thesecond type of stitch is a locking stitch sewn to the cuff and to atleast a portion of the stent.
 5. The prosthetic heart valve of claim 1,wherein the pattern includes two adjacent stitches of the first typefollowed by a single stitch of the second type.
 6. The prosthetic heartvalve of claim 1, wherein the plurality of struts form horseshoe-shapedends at the inflow end of the stent, and the pattern of stitches couplesthe cuff to the horseshoe-shaped ends.
 7. The prosthetic heart valve ofclaim 6, wherein the pattern of stitches includes locking stitches sewnonly to the cuff between the horseshoe-shaped ends.
 8. The prostheticheart valve of claim 1, wherein each of the plurality of cells hasapices, and the stitches sewn to both the cuff and the stent are coupledto proximal-most ones of the apices.
 9. The prosthetic heart valve ofclaim 1, wherein the stitches sewn to both the cuff and the stent arecoupled to a single location of each of a number of the plurality ofcells.
 10. A method of making a prosthetic heart valve, comprising:providing a collapsible and expandable stent having an inflow end at aproximal end, an outflow end at a distal end, an annulus sectionadjacent the inflow end and an aortic section adjacent the outflow end,the stent including a plurality of struts forming a plurality of cellsdisposed in rows; coupling a cuff to the stent so that a flat bottomedge of the cuff lies adjacent the inflow end of the stent so that thecuff fully covers each cell of a proximal-most row of cells closest tothe inflow end of the stent; and sewing a pattern of stitchescircumferentially around the flat bottom edge of the cuff, the patternof stitches alternating between stitches of a first type having a firstshape and sewn to the cuff only and stitches of a second type having asecond shape different from the first shape and sewn to both the cuffand the stent.
 11. The method of claim 10, wherein sewing the pattern ofstitches comprises forming a plurality of locking stitches.
 12. Themethod of claim 10, wherein sewing a pattern of stitches comprisessewing a recurring pattern comprised of the first type of stitch and thesecond type of stitch.
 13. The method of claim 10, wherein sewing apattern of stitches comprises sewing a first type of stitch that is alocking stitch sewn to the cuff only.